Abstract
Frailty is a syndrome associated with reduced physiological reserves that increases an individual's vulnerability for developing increased morbidity and/or mortality. While most clinical trials have focused on exercise, nutrition, pharmacologic agents, or a multifactorial approach for the prevention and attenuation of frailty, none have studied the use of cell-based therapies. We hypothesize that the application of allogeneic human mesenchymal stem cells (allo-hMSCs) as a therapeutic agent for individuals with frailty is safe and efficacious. The CRATUS trial comprises an initial non-blinded phase I study, followed by a blinded, randomized phase I/II study (with an optional follow-up phase) that will address the safety and pre-specified beneficial effects in patients with the aging frailty syndrome. In the initial phase I protocol, allo-hMSCs will be administered in escalating doses via peripheral intravenous infusion (n=15) to patients allocated to three treatment groups: Group 1 (n=5, 20 million allo-hMSCs), Group 2 (n=5, 100 million allo-hMSCs), and Group 3 (n=5, 200 million allo-hMSCs). Subsequently, in the randomized phase, allo-hMSCs or matched placebo will be administered to patients (n=30) randomly allocated in a 1:1:1 ratio to one of two doses of MSCs versus placebo: Group A (n=10, 100 million allo-hMSCs), Group B (n=10, 200 million allo-hMSCs), and Group C (n=10, placebo). Primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCs administered in frail older individuals. This study will determine the safety of intravenous infusion of stem cells and compare phenotypic outcomes in patients with aging frailty.
Highlights
Frailty is defined as a medical condition, which can be caused by multiple stressors, characterized by decreased strength, endurance, and physiologic function that increases the risk of developing dependency and/or mortality [1]
We hypothesize that the application of allogeneic human mesenchymal stem cells as a therapeutic agent for individuals with frailty is safe and efficacious
In the initial phase I protocol, allo-human mesenchymal stem cells (hMSCs) will be administered in escalating doses via peripheral intravenous infusion (n=15) to patients allocated to three treatment groups: Group 1 (n=5, 20 million allo-hMSCs), Group 2 (n=5, 100 million allo-hMSCs), and Group 3 (n=5, 200 million allo-hMSCs)
Summary
Frailty is defined as a medical condition, which can be caused by multiple stressors, characterized by decreased strength, endurance, and physiologic function that increases the risk of developing dependency and/or mortality [1]. The etiology of these increased risks can be, at least partially, attributed to the critically low “reserve capacity” of various organ systems, at which point a minor disturbance can create a cascade of medically catastrophic events [2]. This study will test the safety of intravenous (IV) infusion of allo-hMSCs in frail subjects and will assess the efficacy of treatment in this population at risk for morbidity and mortality
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